COVID-19 Vaccines Performance Decline--Only 38% of At Risk Immunocompromised Kept out of Hospital

TrialSite continues to monitor the observational study output of the Centers for Disease Control and Prevention (CDC) funded VISION Network, a research collaboration involving multiple hospitals/sites with integrated electronic health records (EHR) across America. This is part of an ongoing real-world data effort to evaluate how well vaccines protect against seasonal viruses such as influenza or COVID-19.

In this latest study, the substantial VISION team utilizes a test-negative design to estimate COVID-19 vaccine effectiveness (VE). And the outcomes are not great, in fact, some could argue this latest vaccine bombed.

Why? Any commercial vaccine designed to keep people, especially at-risk cohorts out of the hospital, should perform at least at 50% vaccine effectiveness. At 38% between days 7-59 and 34% in the 60-119 days after the receipt of the updated dose, the only reason CDC can justify recommending the product includes A) because they are not considering full safety risks for this cohort and B) the logic that 38% protected is better than no one and for this latter point there is some rationale. Only 14% of immunocompromised opted to get the vaccine suggesting a near collapse in market demand for COVID-19 vaccines given the risks associated with this demographic.

The data reported herein results from the CDC’s latest Morbidity and Mortality Report (MMWR) titled “Interim Effectiveness of Updated 2023-2024 (Monovalent XBB.1.5) COVID-19 Vaccines Against COVID-19–Associated Hospitalization Among Adults Aged ≥18 Years with Immunocompromising Conditions — VISION Network, September 2023–February 2024.

Background

By September 2021, the CDC’s Advisory Committee on Immunization Practices recommended updating 2023–2024 (monovalent XBB.1.5) COVID-19 vaccination for all persons aged ≥6 months to prevent COVID-19, including severe disease. The agency did not consider a risk-based approach like in most other nations at this point given the following:

Omicron has become much milder (e.g., case fatality rate at the level of influenza for most)

Large segments of the U.S. population have pre-existing immunity at some level

Growing recognition that some safety signals present (e.g., risk of myocarditis/pericarditis in young males, etc.).

Available treatments such as Paxlovid—while not accepted yet by the National Institutes of Health or the CDC,

accumulation of data that vitamin D supplementation very important to avoid more severe symptomatic COVID-19

The CDC suggests additional boosters for immunocompromised conditions should be considered, in this case representing a risk-based approach to public health.

In this latest observational study, the study team assesses how well the COVID-19 vaccines perform at helping immunocompromised persons infected with COVID-19 avoid hospitalization based on the data linked to hospitalization during the period September 2023-February 2024.

Findings

Few persons (18%) in this high-risk study population had received the updated COVID-19 vaccine. All persons aged ≥6 months should receive updated 2023–2024 COVID-19 vaccination; persons with immunocompromising conditions may get additional updated COVID-19 vaccine doses ≥2 months after the last recommended COVID-19 vaccine.

Out of 14,586 patients with immunocompromising conditions who were hospitalized with COVID–19–like illness, the study team included 1,392 case patients and 13,194 control patients.

The most common immunocompromising conditions among both case patients and control patients were solid organ malignancy (36% and 43%, respectively) and other intrinsic immune conditions or immunodeficiency (38% and 35%, respectively).

A total of 195 (14%) case patients had received an updated COVID-19 vaccine dose compared with 2,401 (18%) control patients. VE against COVID–19–associated hospitalization was 38% in the first

More Specifics

The CDC-funded VISION team reports only nine persons who received >1 updated COVID-19 vaccine dose were included!

The team estimated Odds ratios (ORs) using multivariable logistic regression comparing persons who received an updated COVID-19 vaccine dose with those who did not, irrespective of the number of previous original or bivalent COVID-19 vaccine doses received (if any), among case- and control patients.

They adjusted their regression models for age, sex, race and ethnicity, calendar time, and geographic region. While they calculated VE as (1 − adjusted OR) × 100%. Analyses were conducted using R software (version 4.3.2; R Foundation). This activity was reviewed by CDC, deemed not research, and was conducted consistent with applicable federal law and CDC policy.†† VISION activities were reviewed and approved by the Westat and site institutional review boards.

How does CDC rationalize this VE?

According to the VISION team, “Effectiveness estimates in this report were slightly lower than those in a recently published analysis from VISION and another CDC VE network showing COVID-19 VE against COVID-19-associated hospitalizations in adults without immunocompromising conditions was approximately 50%, but this report includes the analysis of an additional month of data compared with the previous report.”

The group still implies recommended vaccination because “persons with moderate or severe immunocompromising conditions are at higher risk for severe COVID-19 and might have decreased response to vaccination.” (2).

Limitations

The VISION team discloses two primary limitations to this study. These include the following:

The use of selected discharge diagnoses as surrogates for presumed immunocompromised status and the absence of medication and other relevant data might have led to misclassification of immunocompromise status, which might have biased estimated VE in either direction

Immunocompromising conditions are heterogeneous and likely to create differential risk for severe COVID-19, as well as differential response to vaccination

CDC suggested implications

Although the VE of 38% to keep immunocompromised individuals out of the hospital evidences a waning performance (in fact under 50% and regulators used to question the overall value of the vaccine), the CDC team argues that “receipt of an updated COVID-19 vaccine dose provided increased protection against COVID-19–associated hospitalization among adults with immunocompromising conditions compared with no receipt of an updated dose.”

And the CDC takes the increasingly unpopular and isolated decision to continue to recommend that all Americans age ≥6 should get the 2023-2024 COVID-19 vaccine, regardless of fundamentally changing risk-benefit calculus.

That only 14% of the immunocompromised population opted to get this latest vaccine is most certainly telling of the market’s proclivity to go out and opt for this vaccine. At TrialSite, we have reported on a growing number of peer-reviewed studies evidencing instability in the current mRNA platforms. Is it a good idea to vaccinate children 6 months and above en masse given the risk-benefit calculus factors discussed above? Even the New York Times recently reported on the fact that the U.S. was now an outlier in recommending systematic COVID-19 vaccination of young children, especially when we factor in risks for myocarditis/pericarditis in young healthy males.

We suggest this latest vaccine effectiveness performance portends an ominous future for this class of vaccine.

TrialSite Critical View

The protection of mRNA vaccines is so transient TrialSite suggests a new metric for their assessment, at least when it comes to protection against infection. Peak efficacy in the first few weeks’ post immunisation is clearly completely irrelevant. What about calculating average 6- or 12-month efficacy?

This would be akin to measuring area under survival curve. Hence depending on the shape of the curve a vaccine that had 90% efficacy at two weeks and 10% efficacy at six months, may have an overall 6-month efficacy of say 20% if the curve falls steeply at the start or 60% if it falls steeply at the end.

We know from the Israeli data in July 2021 that Pfizer had fallen to just 12% efficacy at 6 months so its true overall 6-month efficacy must have been less than 50% even although they continued to quote >90% efficacy in the media.

Also say a vaccine drops from 90% efficacy at two weeks to 0% efficacy at 4 months – how then to describe its overall efficacy over 6 months – intuitively it should be 0% not the average as over the last two months no one is protected, so everyone will now get infected if exposed, even if they got some protection over the first 4 months – i.e. their infection was just delayed.

This requires sophisticated biostatistician input. After all, COVID-19 infections are not linear over time, but highly clustered into outbreaks. If an outbreak occurs at the 5-month post vaccine point in the previous example, then true vaccine efficacy is 0% or may even go negative at least when measuring protection against infection.

https://www.trialsitenews.com/a/cdc-vision-study-covid-19-vaccines-performance-decline-only-38-at-risk-immunocompromised-kept-out-of-hospital-1afb2124

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http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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